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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulase, Human, Horse And Rabbit
510(k) Number K950706
Device Name DRYSLIDE COAGULASE
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Applicant Contact DAVID W GATES
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232 -7058
Correspondent Contact DAVID W GATES
Regulation Number866.2160
Classification Product Code
JTL  
Date Received02/15/1995
Decision Date 05/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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